Presented by
Management Forum

Advanced Veterinary Pharmacovigilance

Including the main requirements of Volume IXB, an update on the proposed EU Regulation (2019/6) on Veterinary Medicinal Products and the impact of Brexit

24-25 Nov 2021 + 4 more dates

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  • Format: Live online, Classroom
  • CPD: 12 hours for your records
  • Certificate of completion

Course overview

The purpose of this seminar is to provide a comprehensive, yet practical, assessment of the main requirements of Volume IXB, the new key document on pharmacovigilance guidelines used by the veterinary regulatory authorities to ensure a compliant reporting company. The programme will also consider the potential impact of Brexit on pharmacovigilance and the implications of the proposed EU Regulation (2019/6) on Veterinary Medicinal Products.

Interactive sessions throughout the two days will give delegates the opportunity to discuss key issues of current concern with our experienced trainer.

Programme to include:

  • Overview of European regulatory framework
  • The key requirements of Volume IXB
  • The detailed description of the pharmacovigilance system (DDPS) and the pharmacovigilance system master file (PSMF)
  • PV training
  • Product safety reviews
  • Company core safety information compliance and PV
  • PV reporting in licensing/distribution agreements
  • Signal detection
  • Benefit-risk assessments
  • Risk management
  • Crisis management
  • Implications of the proposed EU pharmacovigilance legislation

Who should attend?

This seminar will be beneficial to those who have some experience of veterinary pharmacovigilance and is a good follow-on course from the Introduction to Veterinary Pharmacovigilance, which is also run by Management Forum. Adverse event monitoring and drug safety officers, including QPPVs and deputy QPPVs, together with personnel from regulatory affairs and registration departments, will find this event useful.

The course can be used as part of the training to become a QPPV or deputy QPPV

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The Advanced Veterinary Pharmacovigilance course will cover:

The DDPS and the PSMF

  • The DDPS
  • The DDPS – what happens now?
  • The PSMF – purpose and maintenance
  • Transition from DDPS to PSMF

PV training

  • Requirements for PV training
  • Who trains whom and when?
  • Training records, maintenance and updates
  • Role of QA and HR in training

Product safety reviews

  • The safety review committee
  • Timings for safety review
  • Record keeping for safety review meetings

Company core safety information

  • Core safety information
  • How to determine what to include and what to exclude in a company core data sheet (CCDS)
  • Maintenance and development of a CCDS

Compliance and PV

  • Basic principles
  • Measuring compliance
  • Quality versus quantity in safety reports

PV reporting in licensing/distribution agreements

  • What types of agreements exist?
  • Audits of pharmacovigilance capabilities in partners
  • What agreements need to be in place for PV reporting?
  • PV reporting agreements – what needs to be covered?
  • Monitoring PV agreements – what happens if it goes wrong?

Signal detection/benefit-risk and risk management

  • The pharmacovigilance system
  • Signal detection and analysis: what is required?
  • Benefit-risk assessments
  • Risk management/minimisation
  • Crisis management
  • Communication with the public

Audits and inspections: are you ready?

  • What are inspectors looking for?
  • Inspection findings and outcomes
  • Implications of the proposed EU pharmacovigilance legislation

Risk Management Dealing with an Alert

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Declan O'Rourke

Declan O’Rourke has over 20 years’ experience in industry where he has held technical, marketing, product development, clinical development, production and pharmacovigilance roles.

He is a veterinary surgeon, holds a Diploma in Marketing, a Master of Business Administration and a Fellowship of the Royal College of Veterinary Surgeons. He now directs Ortec PV Consultancy Ireland specialising in pharmacovigilance and represented IFAH-EU in the VICH Working Group on pharmacovigilance.

He is Honorary Associate Professor in Veterinary Pharmaceutical Development at Nottingham Veterinary School and Past President of British Cattle Veterinary Association.

More details

Book Advanced Veterinary Pharmacovigilance Live online/Classroom training

24-25 Nov 2021

Live online

09:30-17:00 UK (London) (UTC+00)
10:30-18:00 Paris (UTC+01)
04:30-12:00 New York (UTC-05)
Course code 11156

  • GBP 1,199
  • EUR 1,719
  • USD 1,942

Limited places remaining

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1-2 Feb 2022

Classroom
London venue TBC

08:30-17:00 UK (London)
Course code 11841

  • GBP 1,199 1,399
  • EUR 1,679 1,959
  • USD 1,870 2,182

Until 28 Dec

  • 2 days classroom-based training
  • Meet presenters and fellow attendees in person
  • Lunch and refreshments provided
  • Download documentation and certification of completion
  • Fair transfer and cancellation policy

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4-5 May 2022

Live online

09:30-17:00 UK (London) (UTC+01)
10:30-18:00 Paris (UTC+02)
04:30-12:00 New York (UTC-04)
Course code 11666

  • GBP 999 1,199
  • EUR 1,439 1,719
  • USD 1,630 1,942

Until 30 Mar

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1-2 Aug 2022

Classroom
London venue TBC

08:30-17:00 UK (London)
Course code 11842

  • GBP 1,199 1,399
  • EUR 1,679 1,959
  • USD 1,870 2,182

Until 27 Jun

  • 2 days classroom-based training
  • Meet presenters and fellow attendees in person
  • Lunch and refreshments provided
  • Download documentation and certification of completion
  • Fair transfer and cancellation policy

View basket 

21-22 Nov 2022

Live online

09:30-17:00 UK (London) (UTC+00)
10:30-18:00 Paris (UTC+01)
04:30-12:00 New York (UTC-05)
Course code 11773

  • GBP 999 1,199
  • EUR 1,439 1,719
  • USD 1,630 1,942

Until 17 Oct

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Reviews of IPI's Advanced Veterinary Pharmacovigilance training course


This was a very valuable course which I would highly recommend to other professionals in the industry. I couldn't have asked for a better speaker to be honest. I found Declan very honest and forthcoming with information and opinions. He provided clear and concise responses to any queries (I had a few haha) and was very approachable. The presentations were thorough and it was clear that a lot of effort was put in to ensure that all areas were covered. The webinar organisation and customer service is fantastic. Staff are extremely attentive and a pleasure to deal with.

Jun 23 2021

Kiera Hamilton
Pharmacovigilance Manager, Norbrook Laboratories Limited

Jun 23 2021

Very informative. The course lived up to all my expectations.

Marianne Valentin Hansen
Drug Safety Specialist, Pharmacosmos

Nov 25 2020

I really enjoyed the webinar and Declan did a really really good job! I really appreciated all the cases and examples he gave to us of his own experience.

Julia Urich
Veterinarian, Richter Pharma AG

Nov 25 2020

The webinar was very well organized. We got all needed information in advance, the speaker was amazing and the presentation focused on all aspects of PV.

Jan Subert
New Business Development Manager, Cymedica s.r.o.

Nov 25 2020

Not easy to make such 2 days-training not face 2 face, but the sharing of a lot of examples, and experiences kept my focus on !

Fanny Bellebeau-Barbier
Local responsible of pharmacovigilance, Boehringer Ingelheim

Nov 25 2020

Very good

Tone Madsen
Regulatory Affairs Manager / QPPV, Pharmaq AS, part of Zoetis

Nov 25 2020

Good, enjoyed it and learned a lot.

Lisa Glen
Project Manager, Benchmark Animal Health

Nov 25 2020

Very Good. Excellent topic and well prepared.

Sean O'Sullivan
Bimeda Animal Health Ireland

Nov 25 2020

Excellent

Gaultier Purper
QP, Reprobiol SPRL

Nov 25 2020

I am very happy for having joined the course and for getting very good materials (presentations) and references from it, very didactic.

Maria Bermudez Espinosa
Doctor, LETI

Dec 11 2019

I really enjoyed this course. The interactions with other participants and the flexibility of the speaker to engage in real-world scenarios helped to put the course content into perspective. It was nice to know that other companies face similar challenges, and get practical solutions and advice from the speaker.

Amanda Dwyer
Pharmacovigilance Manager, North America, Elanco Animal Heallth

Mar 13 2019

Excellent, well organised.

Nathalie Frontczak
QPPV, Boehringer Ingelheim

Mar 13 2019

Brilliant content and great speaker.

Danny Wise
Administrative Officer, Veterinary Medicines Directorate

Mar 13 2019

The course was really useful, contained good information and moved at an appropriate pace.

Andrea Smith
Pharmacovigilance Team Leader, Boehringer Ingelheim Animal Health GmbH

Mar 13 2019

An excellent course, well presented.

David Collins
Veterinarian, David Collins

Mar 13 2019

Overall a good course.

Heetika Malik
QPPV, Interchemie werken "De Adelaar" B.V

Oct 2 2018

Excellent. The course was enjoyable, had lots of relevant examples and contained a variety of industry background which also added further benefits and learning opportunities, particularly through group discussions.

Jennifer Hynes
Site Head of Quality, Benchmark Vaccines Limited

Oct 2 2018

Very, very good. I liked Declan's way of presenting and teaching.

Luciano Gobbi
Associate Director Regulatory Affairs, MSD Animal Health SRL

Oct 2 2018

Good speaker, up-to-date materials and plenty of case studies. Excellent and very clear course, well delivered with plenty of opportunity for interactive discussion.

Ruth Clements
Head of Pharmacovigilance, Benchmark

Mar 21 2018

I am very pleased to participate in this veterinary pharmacovigilance training by an expert in the field. The course materials were very well presented and the organization of the training course was perfect.

Hyun Jung HAN GANNEAU
Pharmacovigilance Associate (Vet), AB Science

Mar 21 2018

Very knowledgeable and friendly expert!

Anna Sinjuk
Regulatory Affairs Specialist, Interchemie Werken De Adelaar Eesti AS

Mar 21 2018

Content was appropriate for the course title, it is a great follow on from basic training. A clear presentation – Declan is always articulate and has a good way of explaining things, especially when room is full of non- native English speakers.

Jennifer Blenkinsop
Pharmacovigilance VRO, Veterinary Medicines Directorate

Mar 21 2018

Useful for my daily tasks.

Raffaella Focosi-Snyman
Pharmacovigilance HSO, Veterinary Medicines Directorate

Sep 26 2017

Very thought provoking, many topics covered in detail, very friendly staff. Plenty of reading for me to do afterwards.

Nadine Anderson
Pharmacovigilance VRO, Veterinary Medicines Directorate

Mar 8 2017

I think the course is presented in a brilliant manner and contains great informative content.

Jamie Jardine
Administrative Officer, Veterinary Medicines Directorate

Mar 8 2017

It is good course, covers major topics in PV.

Shahid Soomro
Head of Scientific Department , Bremer Pharma GmbH

Mar 8 2017

Great speaker, very informative.

Jamie Jardine
Administrative Officer, Veterinary Medicines Directorate

Mar 8 2017

Knowledgeable presenter with a lot of experience, nice to have regulators amongst us.

Angela van der Salm
Director Pharmacovigilance, DADA Consultancy

Mar 8 2017

Good.

Elisa Ursich
Pharmacovigilance - VRO, Veterinary Medicines Directorate

Sep 21 2016

There was a lot of examples and experiences told. Speaker was very available.

Tina Mele
Independent Researcher Drug Safety, KRKA d.d. Novo mesto

Sep 21 2016

Interesting, engaging and very useful. I will be recommending it

Caroline Mullen
Pharmacovigilance Officer, Boehringer Ingelheim

Sep 21 2016

Content – good. Presentation and speaker - good presenting and discussion over issues raised by delegates

Lynne Braidwood
Lead Monitor, Veterinary Clinical Studies, Triveritas

Sep 21 2016

Overall, I think it was a very complete course, presented in an orderly and clean fashion. The speaker was very open for discussion and presented the course very lively.

Renée Alberda
Supervisor Regulatory Affairs, Kepro B.V.

Sep 21 2016

Speaker speaks well and was open to our questions and concerns.

Anu Miettinen
Drug Safety Expert, Oy Medfiles Ltd.

Sep 21 2016

Great course and great speaker

Luis Marinas Pardo
Chief Scientific Officer, Centauri Biotech

UK

  • Agrimin Ltd
  • Benchmark
  • benchmark Animal Health
  • Benchmark Vaccines Limited
  • Benchmark Vaccines Ltd
  • Boehringer Ingelheim
  • Boehringer Ingelheim Animal Health
  • Cross Vetpharm Group UK Ltd
  • Cyton Biosciences Ltd
  • David Collins
  • Dechra Ltd
  • Eco Animal Health Ltd
  • Norbrook Laboratories Limited
  • Norbrook Laboratories Ltd
  • Triveritas
  • Veterinary Medicines Directorate
  • Vetpharm Ltd
  • VRe Consulting Limited

Netherlands

  • Beaphar B.V.
  • Beaphar BV
  • DADA Consultancy
  • DADA Consultancy BV
  • Dopharma Research B.V.
  • Dopharma Research BV
  • Interchemie werken "De Adelaar" B.V
  • Kepro B.V.
  • Kepro BV
  • Le Vet Pharma

Germany

  • Bayer AG
  • Bayer Animal Health
  • Boehringer Ingelheim Animal Health GmbH
  • Boehringer Ingelheim Pharma GmbH & Co KG
  • Boehringer Ingelheim Vetmedica GmbH
  • Bremer Pharma GmbH
  • MSD Animal Health
  • MSD Animal Health Innovation GmbH
  • Zoetis Deutschland GmbH

France

  • AB Science
  • Boehringer Ingelheim
  • Ceva Santé Animale
  • Merial
  • Merial - Boehringer Ingelheim
  • VIRBAC

Italy

  • FATRO S.p.A
  • Fatro Spa
  • G.A.B.A. S.r.l.
  • MSD Animal Health SRL
  • Teknofarma S.r.l.

Denmark

  • Merial Norden A/S
  • Pharmacosmos
  • Pharmacosmos A/S
  • PharmAdvice

Norway

  • ACD Pharmaceuticals AS
  • Pharmaq AS
  • Pharmaq AS, part of Zoetis
  • Scan Aqua AS

Austria

  • Boehringer Ingelheim
  • Boehringer Ingelheim RCV GmbH & Co KG
  • RICHTER PHARMA AG

Belgium

  • Delaval NV
  • Reprobiol SPRL
  • Zoetis

Finland

  • Orion Corporation Orion Pharma
  • Oy Medfiles Ltd.
  • Vetcare Oy

Ireland

  • Bimeda Animal Health Ireland
  • Hygeia
  • TriviumVet

Spain

  • Centauri Biotech
  • LETI
  • Vetpharma Animal Health, S.L.

Czech Republic

  • Cymedica s.r.o.
  • Dyntec sro.

Slovenia

  • Billev farmacija vzhod d.o.o
  • KRKA d.d. Novo mesto

Sweden

  • Pharmaxim AB
  • Sofus Regulatory Affairs

Australia

  • Bayer Animal Health

Canada

  • Elanco Animal Heallth

Estonia

  • Interchemie Werken De Adelaar Eesti AS

Hungary

  • Boehringer Ingelheim RCV GmbH & Co KG

Lithuania

  • Interchemie werken "De Adelaar" LT

Portugal

  • Hifarmax, Produtos e Serviços Veterinários, Lda.

Switzerland

  • Bayer Pharmaceuticals

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Multiple colleagues?
Talk to one of our training experts to discuss how to:

Run this course conveniently and cost-effectively in-house for your staff and colleagues

Aleksandra BEER
Training expert

+44 (0)20 7749 4749

inhouse@ipi.academy